Gauge the impact: What does the striking down of a federal copay accumulator regulation mean for patients and copay programs?

What Happened?

On Monday, October 2, a United States District Court struck down a 2021 federal regulation that facilitated commercial payers and pharmacy benefit managers (PBMs) to require enrolled patients to pay more for select specialty medications. In its 2021 Notice of Benefit and Payment Parameters (NBPP), the Centers for Medicare & Medicaid Services (CMS) allowed commercial insurers to deploy copay accumulator adjustment programs—which exclude manufacturer-sponsored copay assistance from counting towards a patient’s out-of-pocket cost calculation—for any drug regardless of if a generic equivalent is available or not. According to the ruling, commercial insurers must now abide by the requirements of the 2020 NBPP, which will only allow these restrictive programs for products with a generic equivalent and in states without laws prohibiting them.

 What Does this Mean for Patients Now?
The ruling is an unequivocal victory for patients who have been affected by these programs as these programs have saturated the commercial market in recent years. According to a survey of commercial payers via Cencora’s consulting team’s Managed Care Network (MCN) of payer advisors, nearly 75% of surveyed payers restrict the use of copay assistance through one of these models.¹

With the reversal, patients now may utilize copay assistance with the financial support counting toward their OOP cost calculation for the purposes of hitting their commercial insurer OOP maximum. Overall, this may help patients reach their OOP maximums more quickly, essentially removing their financial obligations for the rest of the year. Under accumulators, patients may exhaust the manufacturer copay benefit well in advance of coming close to exhausting the plan OOP maximum. Now, patients are unlikely to be in this challenging financial situation (for products without a generic equivalent).

How Should Your Copay Program React?

The ruling also is a significant victory for manufacturer-sponsored copay assistance programs. In addition to helping patients, this ruling may also help reduce the financial impact to copay assistance programs. As this ruling does not fully eradicate copay accumulator adjustment programs altogether, below are key considerations for navigating this new landscape.

• Evaluate the impact of the ruling on your brands to determine which ones are off the table and which ones are likely to face these programs moving forward
• Model the change in financial liability for your copay programs given the changes
• Assess changes to your copay program criteria and parameters
• Devise a new copay program strategy for the new landscape and adapt accumulator solutions for impacted patients